Monitoring hepatitis C treatment
uptake in Australia Issue #2 June 20161
Reimbursements for new treatment for chronic hepatitis C during March and April 2016
A total of 6,503 patient PBS initial prescriptions were processed for reimbursement in March-April 2016. Based on extrapolation of wholesale data to PBS reimbursement data, to account for the time lag in reporting, an estimated 13,000 – 16,250 patients initiated hepatitis C treatment in March-April 2016. New treatments for chronic hepatitis C virus (HCV) infection, named direct acting antiviral (DAA) therapy, were recently listed on the Pharmaceutical Benefits Scheme (PBS): sofosbuvir/ledipasvir (Harvoni®), sofosbuvir/daclatasvir (Sovaldi®/Daklinza®), sofosbuvir/ribavirin (Sovaldi®/Ibavyr®), and sofosbuvir/ pegylated interferon-alfa-2a/ribavirin (Sovaldi®/ Pegysus®/ribavirin) in March 2016, and ombitasvir/ paritaprevir/ritonavir/dasabuvir (Viekira PAK®) in May 2016. Issue #2 newsletter provides the estimated total number of patients with chronic HCV who initiated treatment during March and April 2016, and detailed data on the smaller sample of patients with PBS reimbursement-based prescriptions.
1. The Kirby Institute. Monitoring hepatitis C treatment uptake in Australia (Issue 2). The Kirby Institute, UNSW Australia, Sydney, Australia, June 2016
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Estimated total hepatitis C treatment initiations Based on extrapolation of wholesale data to PBS reimbursement data, to account for the time lag in reporting, an estimated 13,000 – 16,250 patients initiated chronic HCV treatment in March-April 2016.
Hepatitis C prescriptions processed by the PBS by jurisdiction, PBS scheme, and regimen A total of 6,503 individuals had chronic HCV DAA initial prescriptions processed by the PBS during March and April 2016, including 32% (n=2,102) in New South Wales, 32% (n=2,071) in Victoria, 21% (n=1,397) in Queensland, and 14% (n=933) in the other jurisdictions (Figure 1). Further information for individual jurisdictions are provided in Table 1. The higher numbers for April compared to March in all jurisdictions does not represent an increase in treatment initiations, but relates to the time lag in PBS reimbursement-based reporting (it is likely that a majority of April PBS reimbursements are for patients initiated in March).
Number of prescriptions processed for reimbursement
Figure 1: Number of chronic HCV DAA initial prescriptions processed for reimbursement by the PBS during March and April 2016 in Australia, by jurisdiction 2200 2000
April
1800
March
1600
Most individuals (82%) were prescribed under the General Schedule (S85), 18% under S100 HSD Public and <1% under S100 HSD Private (Figure 2). The 18% for S100 is an increase from the 9% in Issue #1, which may indicate a longer lag for S100 versus S85 scheme reimbursement reporting, rather than an actual increase in S100 prescribing.
Figure 2: Distribution of PBS schedule of chronic HCV DAA prescriptions during March-April 2016 in Australia 0.5% General Schedule (S85) 17.8%
S100 HSD Private S100 HSD Public 81.7%
The most commonly prescribed regimen was sofosbuvir/ledipasvir, for 61% (n=3,991), followed by sofosbuvir/daclatasvir for 35% (n=2,305), and sofosbuvir/other agents for 3% (n=207; Figure 3). Other agents would include ribavirin, or pegylated interferon-alfa-2a/ribavirin.
Figure 3: Distribution of chronic HCV DAA regimens prescribed during March-April 2016 in Australia
1400
3%
1200
SOF + LDV
1000
SOF + DCV
800
36% SOF + Others
600 400
61%
200
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NSW
VIC
QLD
Other
2
Of individuals initiated on sofosbuvir/ledipasvir (n=3,991), 7% (n=281) were prescribed an 8-week course, 72% (n=2,887) a 12-week course, and 21% (n=823) a 24-week course. Of individuals initiated on sofosbuvir/daclatasvir (n=2,305), 56% (n=1,295) were prescribed a 12-week course, and 44% (n=1,010) a 24-week course. Of individuals initiated on sofosbuvir/other agents (n=207), 98% (n=203) were prescribed a 12-week course, and 2% (n=4) a 24-week course (Figure 4 and Figure 5). The vast majority of patients prescribed sofosbuvir/ daclatasvir for 24 weeks (n=1,010; 44% of total sofosbuvir/daclatasvir) will be individuals with genotype 3 and cirrhosis. Those prescribed sofosbuvir/ledipasvir for 24 weeks (n=823; 21% of total sofosbuvir/ledipasvir) should represent individuals with genotype 1, prior treatment and cirrhosis.
Number of prescriptions processed for reimbursement
Figure 4: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by treatment regimen and treatment course duration
4000
8 weeks
3500
12 weeks
3000
24 weeks
2500 2000 1500 1000 500 0
SOF + LDV
SOF + DCV
SOF + Others
Figure 5: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by treatment regimen, treatment course duration and jurisdiction
Number of prescriptions processed for reimbursement
1400
8 weeks
1200
12 weeks
1000
24 weeks
800 600 400
NSW
VIC
QLD
SOF + Others
SOF + DCV
SOF + LDV
SOF + Others
SOF + DCV
SOF + LDV
SOF + Others
SOF + DCV
SOF + LDV
SOF + Others
SOF + DCV
0
SOF + LDV
200
Other
*SOF: Sofosbuvir; LDV: Ledipasvir; DCV: Daclatasvir ; NSW: New South Wales; VIC: Victoria; QLD: Queensland
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Table 1: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by regimen, jurisdiction and PBS schedule (based on the number of prescriptions processed for reimbursement by PBS) NSW
VIC
QLD
SA
WA
TAS
ACT
NT
Total
LEDIPASVIR + SOFOSBUVIR
General Schedule
24 weeks
169
256
158
22
24
8
0
1
638
LEDIPASVIR + SOFOSBUVIR
S100 HSD Private
24 weeks
0
0
4
0
0
0
0
0
4
LEDIPASVIR + SOFOSBUVIR
S100 HSD Public
24 weeks
90
39
7
1
19
2
16
7
181
LEDIPASVIR + SOFOSBUVIR
General Schedule
12 weeks
742
816
606
97
125
33
9
9
2437
LEDIPASVIR + SOFOSBUVIR
S100 HSD Private
12 weeks
7
3
1
1
1
0
0
0
13
LEDIPASVIR + SOFOSBUVIR
S100 HSD Public
12 weeks
196
91
18
0
33
1
80
18
437
LEDIPASVIR + SOFOSBUVIR
General Schedule
8 weeks
105
49
74
6
4
7
4
0
249
LEDIPASVIR + SOFOSBUVIR
S100 HSD Private
8 weeks
0
0
0
0
0
0
0
0
0
LEDIPASVIR + SOFOSBUVIR
S100 HSD Public
8 weeks
11
6
0
1
0
0
14
0
32
SOFOSBUVIR + DACLATASVIR
General Schedule
24 weeks
180
314
186
37
38
15
6
0
776
SOFOSBUVIR + DACLATASVIR
S100 HSD Private
24 weeks
4
2
1
0
0
0
0
0
7
SOFOSBUVIR + DACLATASVIR
S100 HSD Public
24 weeks
106
47
11
0
19
0
26
18
227
SOFOSBUVIR + DACLATASVIR
General Schedule
12 weeks
317
353
276
50
47
14
9
1
1067
SOFOSBUVIR + DACLATASVIR
S100 HSD Private
12 weeks
6
2
0
0
0
0
0
0
8
SOFOSBUVIR + DACLATASVIR
S100 HSD Public
12 weeks
79
52
10
1
22
0
54
2
220
SOFOSBUVIR + Others
General Schedule
24 weeks
0
0
0
0
0
0
1
0
1
SOFOSBUVIR + Others
S100 HSD Private
24 weeks
1
0
0
0
0
0
0
0
1
SOFOSBUVIR + Others
S100 HSD Public
24 weeks
2
0
0
0
0
0
0
0
2
SOFOSBUVIR + Others
General Schedule
12 weeks
50
31
44
6
5
5
1
0
142
SOFOSBUVIR + Others
S100 HSD Private
12 weeks
2
0
0
0
0
0
0
0
2
SOFOSBUVIR + Others
S100 HSD Public
12 weeks
35
10
1
0
7
0
3
3
59
222
344
85
223
59
6503
Total 2102 2071 1397
*NSW: New South Wales; VIC: Victoria; QLD: Queensland; SA: South Australia; WA: Western Australia; TAS: Tasmania; ACT: Australian Capital Territory; NT: Northern Territory
Methodology Two data sources were used: PBS reports of prescriptions processed for reimbursement, and wholesale expenditure data. PBS reports the number of prescriptions processed for reimbursement on a monthly basis. Pharmacies submit prescriptions for reimbursement 2-12 weeks (generally 2-4 weeks) after dispensing. PBS reports of the number of prescriptions are therefore subject to a time lag between drug dispensing and reimbursement submissions. This lag may also vary by pharmacy type, with potentially longer lags for public hospitalbased pharmacies (S100 scheme) compared to community-based pharmacies (S85 scheme). The wholesale price expenditure on chronic HCV DAA drugs during March and April has been estimated
at 2.25 times wholesale price equivalent for PBS reimbursements reported for the same period.2,3 For the estimate of the number of patients initiated on HCV treatment during March-April 2016, we have used a range of 2.00-2.50 (rather than 2.25) given inherent uncertainties within this methodology. Two assumptions have been made in reporting of the PBS reimbursement data, and in extrapolation: 1) All patients who initiated treatment in March have continued treatment in April, given that the shortest duration therapy is 8 weeks (aggregated monthly data is provided by PBS, rather than individual patient data). The aggregated numbers reported for the month of April for each regimen, duration, and scheme will therefore represent all patients initiated in both March and April; 2) The time lag is similar for patients initiated in March and April.
2. Hep C sales hit half a billion in just nine weeks. PharmaDispatch, 13 May 2016 3. Medicare catching up on HCV therapies. PharmaDispatch, 26 May 2016
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